Neurotrophic KeratitisPhase 2NCT07568730
A Multicenter, Randomized, Vehicle-Controlled, Double-Masked to Open-Label Study to Evaluate the Safety and Efficacy of Lacripep in Subjects With Neurotrophic Keratitis
A Phase 2 study testing Lacripep in people with Neurotrophic Keratitis, run by TearSolutions, Inc. at 6 sites in United States.
Trial summary
Objective: To evaluate the safety of Lacripep 4 μM Ophthalmic Solution and its effect on the ocular surface, visual function, corneal sensitivity, and quality of life of subjects with Stage 1 NK. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurotrophic Keratitis
- What is being tested?
- Lacripep
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 6 sitesUnited States
- Study dates
- 19 Feb 2026to Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who meet all the following inclusion criteria at Visit 1 (Screening) will be eligible to participate in the study.
- Are ≥18 years of age.
- Provide informed consent before any study-related procedures are performed.
- Are willing and able to comply with study procedures and the study schedule.
- Female subjects must either be incapable of pregnancy or must use an effective method of birth control for the duration of the study. Female subjects of childbearing potential must have a negative pregnancy test and not be nursing.
- Have all of the following in at least one eye:
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- Stage 1 NK as defined by:
- Grade 3 cCFS using the National Eye Institute (NEI) scale (0-3 in one-point increments).
- Corneal sensitivity ≤4 cm in the central zone, as measured by Cochet-Bonnet aesthesiometer.
- BCDVA +0.2 to +1.0 logarithm of the minimum angle of resolution (logMAR) (Snellen equivalent 20/32 to 20/200).
- IOP ≤21 mmHg.
Who cannot join
- Subjects who meet any of the following exclusion criteria at Visit 1 (Screening) will not be eligible to participate in the study. Ocular criteria apply to each eye independently, unless otherwise noted.
- Have received prior treatment with Lacripep Ophthalmic Solution or Oxervate® (cenegermin-bkbj) Ophthalmic Solution within 6 months prior to Visit 1 (Screening) and failed to demonstrate a clinically meaningful response, as determined by the Investigator.
- Have participated in a NK study within 90 days prior to Visit 1 (Screening).
- Have participated in any other clinical study or used an investigational agent within 30 days prior to Screening or plans to participate in another clinical study at any time during the conduct of this study.
- Have a glycated hemoglobin (HbA1c) score >9% within 90 days prior to Visit 1 (Screening).
- Have a history of or current conditions that may confound the study data; such conditions include but are not limited to ocular cicatricial pemphigoid, graft versus host disease, neuromyelitis optica, Stevens-Johnson syndrome, and Salzmann's nodular degeneration.
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- Have an unstable history of severe systemic allergy or severe ocular allergy (including seasonal conjunctivitis expected during the study period) or chronic conjunctivitis and/or keratitis other than dry eye disease.
- Have been diagnosed with glaucoma or are a glaucoma suspect who requires or may require treatment during the study.
- Have, in the opinion of the Investigator, evidence of an active ocular infection (bacterial, viral, protozoal) in either eye.
- Have any intraocular inflammation (Tyndall score >0).
- Have, in the opinion of the Investigator, severe vision loss due to retinal disease, with no potential for visual improvement.
- Have an eyelid abnormality that may alter eyelid function; such abnormalities include but are not limited to blepharospasm, cerebrovascular accident, entropion, ectropion, and floppy lid syndrome.
- Have punctal occlusion or punctal plugs that will not be maintained during the study period.
- Have had any corneal surface procedure within 90 days prior to Visit 1 (Screening). This includes laser-assisted in situ keratomileusis (LASIK), phototherapeutic or photorefractive keratectomy (PTK or PRK), radial keratotomy (RK), small-incision lenticule extraction (SMILE), penetrating keratoplasty (PK), automated lamellar keratoplasty (ALK), deep anterior lamellar keratoplasty (DALK), Descemet membrane endothelial keratoplasty (DMEK), Descemet stripping endothelial keratoplasty (DSEK), superior limbic keratoconjunctivitis (SLK) surgery, and placement of any amniotic membrane.
- Have, in the opinion of the Investigator, NK that was induced by a neurosurgical procedure.
- Have undergone any other ocular surgery (including peripheral iridotomy (PI), laser iridotomy (LI) eyelid surgery and any surgical refractive procedures) within 90 days prior to Visit 1 (Screening) or expect to undergo ocular surgery during the study period.
- Have, in the opinion of the Investigator, history of viral corneal disease that resulted in significant corneal scarring.
- Have viral corneal disease without scarring that is considered unstable prior to Visit 1 (Screening), defined as discontinuation of topical ocular antiviral therapy or topical ocular steroid therapy within 2 weeks prior to Screening, or evidence of viral reactivation during the run-in period.
- Have received Botox (botulinum toxin) ocular injections to induce pharmacologic blepharoptosis within 45 days prior to Visit 1 (Screening).
- Have used any non-study issued eye drops or neurostimulators within 14 days prior to Visit 2 (Day 1; Baseline/Randomization).
- Anticipate a need to use therapeutic contact lenses or unwilling to discontinue wearing contact lenses for refractive correction during the study period.
- Have, in the opinion of the Investigator, an unstable medical condition that may confound the study data; such conditions include but are not limited to diabetes, thyroid disease, autoimmune disease, Parkinson's disease, and multiple sclerosis.
- Evidence of current drug or alcohol abuse or addiction, in the opinion of the Investigator.
- Are pregnant, nursing, or planning a pregnancy during the study period.
- Are an employee of a site directly involved in the management, administration, or support of the study or an immediate family member of the same.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Michelle Carpenter contact
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Midwest Cornea Associates
Carmel, Indiana, 46032
Study Coordinator, 317-817-1765, mcaresearch@midwesteye.com
- Recruiting
Minnesota Eye Consultants
Minneapolis, Minnesota, 55431
Study Coordinator, 952.567.6111, aadreyer@mneye.com
- Recruiting
NYU Langone Center
New York, New York, 10017
Study Coordinator, 929-455-5522, Tonya.Robin@nyulangone.org
- Recruiting
Eye Health Vision Center
Russells Mills, Massachusetts, 02747
Study Coordinator, 508-994-1400 ext. 2105, cfriedman@centuryvisionglobal.com
- Not yet recruiting
Ophthalmology Associates
St Louis, Missouri, 63131
Study Coordinator, 314-966-3377, samayatrawick@eyecare-partners.com
- Recruiting
University of South Florida
Tampa, Florida, 33612
Study Coordinator, (813)974-0948, ssherous@usf.edu
About this study
Official title: A Multicenter, Randomized, Vehicle-Controlled, Double-Masked to Open-Label Study to Evaluate the Safety and Efficacy of Lacripep 4 μM Ophthalmic Solution in Subjects With Neurotrophic Keratitis
Objective: To evaluate the safety of Lacripep 4 μM Ophthalmic Solution and its effect on the ocular surface, visual function, corneal sensitivity, and quality of life of subjects with Stage 1 NK.
Read the detailed description
The study will compare Lacripep 4 μM Ophthalmic Solution to vehicle ophthalmic solution for the treatment of Stage 1 neurotrophic keratitis (NK). Approximately 54 subjects will be enrolled and will enter a 2-week run-in period with open-label vehicle ophthalmic solution. At Visit 2 (Day 1; Baseline/Randomization), eligible subjects will be randomized to either Lacripep 4 μM Ophthalmic Solution or vehicle ophthalmic solution. Subjects will dose three times a day (TID) in both eyes (OU) for 8 weeks, with clinic visits at Week 2, Week 4, and Week 8.
A central reading center will assess study images to ensure objective, standardized, and unbiased grading.
At the Week 8 visit, subjects will be assigned to open-label treatment with Lacripep 4 μM Ophthalmic Solution for 4 weeks, through Week 12. The initiation of 4 weeks of open-label active treatment is designed to explore the potential effects of both a shorter and a longer treatment period: i.e., 4 weeks of active treatment for subjects originally randomized to vehicle ophthalmic solution, and 12 total weeks of active treatment for subjects originally randomized to Lacripep 4 μM Ophthalmic Solution. Subjects will continue to dose TID in both eyes.
All Week 1-8 treatment assignments will remain masked through database lock.
- Conditions
- Neurotrophic Keratitis
- Being tested
- Lacripep, Vehicle Ophthalmic Solution
- Keywords
- Neurotrophic Keratitis, NK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LacripepDrug
Lacripep 4 μM Ophthalmic Solution
Vehicle Ophthalmic SolutionOther
Vehicle ophthalmic solution
| Study group | Role | What they receive |
|---|---|---|
| Lacripep | Experimental | Not described Receives: Drug: Lacripep |
| Vehicle | Placebo comparator | Not described Receives: Other: Vehicle Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy
Change from baseline in cCFS at Week 8 in Study Eye
Measured: Baseline to Week 8
Secondary outcomes (1)
Secondary Efficacy
Change from baseline in central corneal sensitivity at Week 8 in Study Eye
Measured: Baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start19 Feb 2026
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurotrophic KeratitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Multicenter, Randomized, Vehicle-Controlled, Double-Masked to Open-Label Study to Evaluate the Safety and Efficacy of Lacripep Ophthalmic Solution in Subjects with Neurotrophic Keratitis
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TearSolutions, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Odrich, MD, Study director, TearSolutions CMO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568730
- Sponsor's protocol ID
- TS-NK-001
- Status last verified
- Sep 2026
- First submitted
- 28 Apr 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Vehicle-Controlled, Double-Masked to Open-Label Study to Evaluate the Safety and Efficacy of Lacripep 4 μM Ophthalmic Solution in Subjects With Neurotrophic Keratitis
- ClinicalTrials.gov ID
- NCT07568730
- Acronym / sponsor ID
- TS-NK-001
- Conditions
- Neurotrophic Keratitis
- Keywords
- Neurotrophic Keratitis, NK
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- TearSolutions, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Feb 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: To evaluate the safety of Lacripep 4 μM Ophthalmic Solution and its effect on the ocular surface, visual function, corneal sensitivity, and quality of life of subjects with Stage 1 NK.
Detailed description
The study will compare Lacripep 4 μM Ophthalmic Solution to vehicle ophthalmic solution for the treatment of Stage 1 neurotrophic keratitis (NK). Approximately 54 subjects will be enrolled and will enter a 2-week run-in period with open-label vehicle ophthalmic solution. At Visit 2 (Day 1; Baseline/Randomization), eligible subjects will be randomized to either Lacripep 4 μM Ophthalmic Solution or vehicle ophthalmic solution. Subjects will dose three times a day (TID) in both eyes (OU) for 8 weeks, with clinic visits at Week 2, Week 4, and Week 8.
A central reading center will assess study images to ensure objective, standardized, and unbiased grading.
At the Week 8 visit, subjects will be assigned to open-label treatment with Lacripep 4 μM Ophthalmic Solution for 4 weeks, through Week 12. The initiation of 4 weeks of open-label active treatment is designed to explore the potential effects of both a shorter and a longer treatment period: i.e., 4 weeks of active treatment for subjects originally randomized to vehicle ophthalmic solution, and 12 total weeks of active treatment for subjects originally randomized to Lacripep 4 μM Ophthalmic Solution. Subjects will continue to dose TID in both eyes.
All Week 1-8 treatment assignments will remain masked through database lock.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A Multicenter, Randomized, Vehicle-Controlled, Double-Masked to Open-Label Study to Evaluate the Safety and Efficacy of Lacripep Ophthalmic Solution in Subjects with Neurotrophic Keratitis
| Arm | Type | Receives |
|---|---|---|
| Lacripep | Experimental | Drug: Lacripep |
| Vehicle | Placebo comparator | Other: Vehicle Ophthalmic Solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects who meet all the following inclusion criteria at Visit 1 (Screening) will be eligible to participate in the study.
- Are ≥18 years of age.
- Provide informed consent before any study-related procedures are performed.
- Are willing and able to comply with study procedures and the study schedule.
- Female subjects must either be incapable of pregnancy or must use an effective method of birth control for the duration of the study. Female subjects of childbearing potential must have a negative pregnancy test and not be nursing.
Key exclusion criteria (25 listed)
- Subjects who meet any of the following exclusion criteria at Visit 1 (Screening) will not be eligible to participate in the study. Ocular criteria apply to each eye independently, unless otherwise noted.
- Have received prior treatment with Lacripep Ophthalmic Solution or Oxervate® (cenegermin-bkbj) Ophthalmic Solution within 6 months prior to Visit 1 (Screening) and failed to demonstrate a clinically meaningful response, as determined by the Investigator.
- Have participated in a NK study within 90 days prior to Visit 1 (Screening).
- Have participated in any other clinical study or used an investigational agent within 30 days prior to Screening or plans to participate in another clinical study at any time during the conduct of this study.
- Have a glycated hemoglobin (HbA1c) score >9% within 90 days prior to Visit 1 (Screening).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LacripepLacripep 4 μM Ophthalmic Solution | Drug | Lacripep |
| Vehicle Ophthalmic SolutionVehicle ophthalmic solution | Other | Vehicle |
Primary outcome
Primary Efficacy
Time frame: Baseline to Week 8
Change from baseline in cCFS at Week 8 in Study Eye
1 secondary outcome
Secondary Efficacy
Time frame: Baseline to Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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Effect of Acoltremon Ophthalmic Solution 0.003% on Signs and Symptoms of Ocular Surface Disease in Stage I Neurotrophic Keratopathy Patients With Tear Deficiency
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michelle Carpenter contact
Marc Odrich, MD study director
TearSolutions CMO
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lacripep in people with Neurotrophic Keratitis, run by TearSolutions, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc Odrich, MD (646.249.2800, modrich@tearsolutions.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy (time frame: Baseline to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.